drug facts

drug facts

SPL v4

SPL

SPL Set ID 66fd73be-05c8-4905-96f5-f73fa1447b3f

Route

topical

Published

Effective Date 2024-07-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

benzalkonium (1 mg)

Inactive Ingredients

water isopropyl alcohol propylene glycol fd&c red no. 40 fd&c blue no. 1

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2013-10-28 Until 2017-09-28

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.1%

Medication Information

Warnings

For external use only

Uses

for handwashing to decrease bacteria on the skin
recommended for repeated use

Purpose

Antiseptic handwash

Directions

wash hands to remove soil
dispense palmful
spread to cover hands, rub in well
air dry, do not rinse or towel dry

Other Information

for additional information, see Material Safety Data Sheet (MSDS)
for emergency medical information in USA, call 1.800.328.0026

Description

Benzalkonium chloride 0.1%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

Section 51727-6

Inactive ingredients water (aqua), isopropoyl alcohol, propylene glycol, FDC red 40, FDC blue 1

Section 53413-1

Questions? call 1.866.444.7450

Do Not Use

In eyes

Active Ingredient

Benzalkonium chloride 0.1%

When Using This Product

If in eyes, rinse promptly and thoroughly with water
discontinue use if irritation and redness develop

Principal Display Panel With Representative Label

Hand Sanitizing Foam

Active ingredient: Benzalkonium chloride 0.1%

25 FL OZ (750 mL)

Pure Force^™

370 Wabasha Street North Made in U.S.A.

St. Paul, MN 55102 755509/7100/0713

Structured Label Content

Warnings

For external use only

Uses

for handwashing to decrease bacteria on the skin
recommended for repeated use

Purpose

Antiseptic handwash

Directions

wash hands to remove soil
dispense palmful
spread to cover hands, rub in well
air dry, do not rinse or towel dry

Other Information (Other information)

for additional information, see Material Safety Data Sheet (MSDS)
for emergency medical information in USA, call 1.800.328.0026

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

Section 51727-6 (51727-6)

Inactive ingredients water (aqua), isopropoyl alcohol, propylene glycol, FDC red 40, FDC blue 1

Section 53413-1 (53413-1)

Questions? call 1.866.444.7450

Do Not Use (Do not use)

In eyes

Active Ingredient

Benzalkonium chloride 0.1%

When Using This Product (When using this product)

If in eyes, rinse promptly and thoroughly with water
discontinue use if irritation and redness develop

Principal Display Panel With Representative Label (Principal Display Panel with Representative Label)

Hand Sanitizing Foam

Active ingredient: Benzalkonium chloride 0.1%

25 FL OZ (750 mL)

Pure Force^™

370 Wabasha Street North Made in U.S.A.

St. Paul, MN 55102 755509/7100/0713

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for handwashing to decrease bacteria on the skin recommended for repeated use", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50569-3": "Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours", "51727-6": "Inactive ingredients water (aqua), isopropoyl alcohol, propylene glycol, FDC red 40, FDC blue 1", "53413-1": "Questions? call 1.866.444.7450", "Purpose": "Antiseptic handwash", "Warnings": "For external use only", "Directions": "wash hands to remove soil dispense palmful spread to cover hands, rub in well air dry, do not rinse or towel dry", "Do not use": "In eyes", "Active Ingredient": "Benzalkonium chloride 0.1%", "Other information": "for additional information, see Material Safety Data Sheet (MSDS) for emergency medical information in USA, call 1.800.328.0026", "When using this product": "If in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop", "Principal Display Panel with Representative Label": "Hand Sanitizing Foam Active ingredient: Benzalkonium chloride 0.1% 25 FL OZ (750 mL) Pure Force ™ Distributed by: © 2013 Ecolab USA Inc. PureForce All Rights Reserved 370 Wabasha Street North Made in U.S.A. St. Paul, MN 55102 755509/7100/0713"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:16.166199 · Updated: 2026-03-14T23:03:15.788850